The peripheral nervous system comprises the nerves and ganglia that are outside of the central nervous system. The central nervous system, which consists of the brain and spinal cord is connected to the limbs and organs by the peripheral nerves. In general the peripheral nervous system controls both sensory and motor functions.
Because the peripheral nervous system is responsible for processing sensory events, the peripheral nerves are also responsible for processing pain. The peripheral nervous system processes pain associated with syndromes such as scalp pain, extremity pain, migraine, and occipital neuralgia. The peripheral nervous system is also responsible for motor functions. These motor functions include movement of extremities and core.
The nerves of the peripheral nervous system provide a pathway for electrochemical nerve impulses. Impairment of these electrochemical pathways may result in an inability to properly process pain resulting in pain such as scalp pain, extremity pain, migraine, and occipital neuralgia. Impairment of peripheral nerves may also result in impairment of a person's motor abilities.
Neuromodulation has been used to alter the nerve activity through the delivery of electrical stimulation or chemical agents. In neuromodulation, electrical stimulation of peripheral nerves is used for modulating firing patterns of neurons. This electrical stimulation can be accomplished by subcutaneous placement of electrodes proximate to a peripheral nerve. The implantable electrodes currently used for neuromodulation are designed for epidural use. Because epidural electrodes, being used off-label, are not designed for neuromodulation in a subcutaneous location there are several complications including infection, skin erosion, pain and electrode fracture.
Existing and currently used epidural electrodes are all one caliber from distal to proximal ends. This single caliber design means that an electrode that is thin enough to be of lower risk for erosion in the subcutaneous location and lower profile is too fragile when traversing the course to the implanted generator site.
Additional shortcomings of existing electrodes include separate anchor systems that require extra steps for implantation and also introduced movement of the electrode which can affect technical performance.
The frailty and mobility of current electrodes may be overcome by using an electrode that is designed to be used specifically for subcutaneous placement over a peripheral nerve. Such an electrode would have a tapered and thin distal electrode in combination with a more robust, wider diameter lead body that is better able to resist the stresses of high motion areas, especially the range of motion in the neck.
A need exists in the art for devices, systems, and methods for an implantable electrode lead designed for neuromodulation applications requiring subcutaneous placement.
While multiple embodiments are disclosed, still other embodiments of the present disclosure will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the disclosure. As will be realized, the disclosure is capable of modifications in various aspects, all without departing from the spirit and scope of the present disclosure. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.